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LEGAL-EASE: Here Comes the Sunshine Act: Are You Ready?

Do you know what pharmaceutical companies and device manufacturers are saying about your relationships with them?

As of Aug. 1, as part of the Physician Payments Sunshine Act, all pharmaceutical and device companies were required to begin collecting and tracking data on all of their “interactions” with physicians — in other words, payments and other items of value provided — to the Centers for Medicare and Medicaid Services (CMS).

Next year, CMS will launch a searchable website that will make all of this data available to the public.

Many neurologists probably aren't familiar with the Sunshine Act, said James Russell, DO, vice chair of neurology at Lahey Hospital and Medical Center in Burlington, MA, and chair of the AAN's Ethics, Law, and Humanities Committee — who confesses that he himself didn't know much about it before the first week in August either. “My guess is that there is not much grassroots awareness about this.”

That lack of awareness could pose a problem. Physicians themselves don't have to do anything in terms of reporting their industry transactions under the Sunshine Act — but if companies make errors in their reporting, patients could be misled as to the relationships neurologists do and don't have with industry.

The website won't go live until September 2014, but now is the time to make sure that all financial information is in order and that neurologists are prepared to challenge any inaccurate information submitted to CMS, said David Evans, chief operating officer of Texas Neurology, a nine-physician practice in the Dallas area. “If you're going to receive a transfer or a payment, take a lunch, participate in a speaking engagement, or attend something, neurologists should ask whether it is reportable or not.”

WHAT WILL BE REPORTED?

In general, all payments over $10 — including categories such as consulting fees, grants, honoraria, research support — must be reported. There are some exemptions, including accredited CME, product samples not intended to be sold, buffet meals and other generally available conference refreshments, discounts (including rebates), and short-term loans of medical devices on a trial basis. “If you don't want to be in the database, you should clarify,” said Evans, who is chair of the AAN Practice Management and Technology Subcommittee of the Medical Economics and Management Committee. [For more tips on preparing for the Sunshine Act, see “Sunshine Act Checklist.”]

Going forward, Evans advises neurologists to check the upcoming CMS website at least quarterly to ensure that the information reported is correct. “You can't track down to the nickel, but you know if you didn't receive $15,000 from XYZ company,” he said.

Dr. Russell said he plans to deal with any Sunshine Act issues “on a case by case basis.”

“Were something to be published about me out of context, I would research it and respond to it, but I'm not going to go looking for it any more than I go online and look at blogs that rate physicians or registries that talk about malpractice histories,” he said. “It's impossible to anticipate what each of my patients will read and misinterpret on the Internet.”

He believes that Sunshine Act reporting underscores the double-edged sword of transparency. “I think that, for the most part, transparency and informed consent are integral parts of the patient-physician relationship,” he said. “But the very fact that these exist, in my mind at least, points fingers at both pharma and biomedical instrument manufacturers and MDs suggesting that any kind of relationship is an implied ‘bad’ relationship.”

Evans said he is optimistic that the Sunshine Act may actually improve the quality of reporting on financial transactions between physicians and industry. “We monitor the websites that are reporting this kind of information, such as ProPublica, and we've seen this stuff for quite awhile. Because the Sunshine Act is regulated, and there is very specific guidance on how payments are reported, the data may be cleaner and more clearly defined.”

THE SUNSHINE ACT CHECKLIST

* For any industry relationships you have, talk with your representative and ask to review your reportable transfers to ensure accuracy.

* Check to ensure that all your professional information, specialty, and other data are recorded accurately both with any industry reps and in the NPI (National Provider Identifier) database. Especially if your name is, say, “Gary Johnson” or “Jennifer Smith.” The more common your name, the more likely it is that a transaction that isn't yours might get inaccurately linked to you if your other identifying information isn't properly updated. (For example, there are at least two well-known neurologists named James Russell.)

* Download CMS' free “Open Payments” app to your smartphone. (It's available for both Android and Apple devices.) It lets you do your own payment tracking — essential if you want to challenge a report you think is incorrect.

* Prepare to educate your patients. “If you are receiving payments from industry, consider how to communicate that to your patients,” said Evans. “If a patient comes in and says, 'You prescribed me Cambia and I see that you received $3,000 from that company last year,' you'll want to be prepared to answer their questions.”

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